510(k) Report

510(k) · Cleared

Cleared

Quanta Lite Gliadin Igg II

K052142510(k) TraditionalCleared Oct 4, 200557-day reviewClass II21 CFR 866.5750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Inova Diagnostics, Inc. · MST Antibodies, Gliadin

Cleared on Oct 4, 2005 after a 57-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 7 later devices descend from it.

Decided
Oct 4, 2005
Review
57 days
Class
Class II
Product code
MST
Recalls
None
Predicates
0

7 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2013: 1 descendant cleared2010: 1 descendant cleared2012: 1 descendant cleared2019: 1 descendant cleared2021: 2 descendants cleared20052010201520202025
  1. This deviceK052142 Quanta Lite Gliadin Igg IIInova Diagnostics, Inc. · 2005
  2. Descendant · cites it directly · 2 of its ownK113863 Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga…Inova Diagnostics, Inc. · 2012
  3. Descendant · cites it directly · 1 of its ownK093459 Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay…Phadia US, Inc. · 2010 · Recalled
  4. Descendant · 2 generations on · 0 of its ownK200230 Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc. · 2021
  5. Descendant · 2 generations on · 0 of its ownK193604 Aptiva Celiac Disease IgA ReagentInova Diagnostics, Inc. · 2021
  6. Descendant · 2 generations on · 0 of its ownK181871 EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA…Phadia AB · 2019

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2010: 12012: 12013: 12014: 12019: 12021: 2
2010high 2 (2021) · low 0 (2011)2026

Most influential descendants

Showing 5 of 7 · See all
  • K113863Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators, Quanta…Inova Diagnostics, Inc. · 2012 · cites it directly2descendants
  • K093459Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay, Models 14-5538-01…Phadia US, Inc. · 2010 · cites it directly1descendant
  • K200230Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc. · 2021 · 2 generations on0descendants
  • K193604Aptiva Celiac Disease IgA ReagentInova Diagnostics, Inc. · 2021 · 2 generations on0descendants
  • K181871EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG…Phadia AB · 2019 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K052142Quanta Lite Gliadin Igg IIInova Diagnostics, Inc.2005—
+1K113863Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators…Inova Diagnostics, Inc.2012—
+1K093459Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay, Models…Phadia US, Inc.20102
+2K200230Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc.2021—
+2K193604Aptiva Celiac Disease IgA ReagentInova Diagnostics, Inc.2021—
+2K181871EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP…Phadia AB2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201210
201310
201410
201910
202120
FIG. 1 — Lineage of K052142, 2005–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MST? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (7)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K113863Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators, Quanta…Inova Diagnostics, Inc.20122
K093459Elia Gliadin DP Iga Immunoassay and Elia Gliadin DP Igg Immunoassay, Models 14-5538-01…Phadia US, Inc.20101
K140691IG_Plex Celiac DGP PanelSqi Diagnostics Systems, Inc.20140
K130053Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga…Bio-Rad Laboratories, Inc.20130

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K113863 (Inova Diagnostics, Inc., 2012) has gone furthest, with 2 descendants of its own.

How does its category compare?

All MST devices

MST Antibodies, Gliadin: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MST

1in 2017

2007: 22008: 12009: 22010: 22011: 12012: 22013: 12017: 1
2007high 2 (2007) · low 0 (2014)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MST

Too few MST 510(k)s in any year since 2007 to give a median.

Recalls per year · MST

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MST

No MAUDE report names MST since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—00
20081—10
20092—00
20102—00
20111—00
20122—00
20131—00
20140—00
20150—00
20160—00
20171—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The QUANTA Lite Gliadin IgG II is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of gliadin IgG antibodies in human serum. The presence of gliadin antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of celiac disease.

Indications for use as stated in the FDA 510(k) statement.

More from Inova Diagnostics, Inc.

138 FDA decisions under this applicant name. See the company

  • K243979Aptiva APS IgA ReagentInova Diagnostics, Inc. · 2026
  • K223093Aptiva APS IgG Reagent; Aptiva APS IgM ReagentInova Diagnostics, Inc. · 2024
  • K213403Aptiva CTD Essential ReagentInova Diagnostics, Inc. · 2023
  • K200230Aptiva Celiac Disease IgG ReagentInova Diagnostics, Inc. · 2021
  • K193604Aptiva Celiac Disease IgA ReagentInova Diagnostics, Inc. · 2021

Recent decisions in MST

The MST category page

  • K163177ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAImmco Diagnostics, Inc. · 2017
  • K132082Aeskulisa DGP-a, Aeskulisa DGP-G,Aeskulisa DGP-CheckAesku Diagnostics · 2013
  • K113377Gliadin Iga and Gliadin LgaGrifols USA, LLC · 2012
  • K113863Quanta Flash DGP Iga, Quanta Flash DGP Igg, Quanta Flash DGP Iga Calibrators, Quanta Flash DGP Igg CalibratorsInova Diagnostics, Inc. · 2012
  • K111414Quanta Flash (TM) DGP ScreenInova Diagnostics, Inc. · 2011

https://510kreport.com/device/K052142 · printed Nov 5, 2026

Cite this page

510(k) Report. “K052142: Quanta Lite Gliadin Igg II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052142

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026